BIB Stent Placement Catheter— 510(k) K213915

Substantially Equivalent

NuMED, Inc.

FDA 510(k) clearance K213915 for BIB Stent Placement Catheter, Substantially Equivalent on 2022-01-12. Applicant: NuMED, Inc.. Device class: 2.

Clearance details

Applicant: NuMED, Inc.
Product code: Code NVM
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2021-12-15
Decision date: 2022-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Hopkinton, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NVM

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K050857 — BIB PTA BALLOON CATHETER2005-07-28

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Data sourced from openFDA. This site is unofficial and independent of the FDA.